The U.S. Food and Drug Administration recorded an initial approval for Zepbound (tirzepatide) on November 8, 2023. The action was filed under NDA 217806 and identified Eli Lilly and Co. as the sponsor.
Background
Tirzepatide is listed in the supplied FDA record under the product names Zepbound and tirzepatide. Related product names include Zepbound KwikPen, Mounjaro, and Mounjaro KwikPen. The data identify the application as a new indication submitted as a distinct NDA and not consolidated with another application.
The supplied record does not specify the approved indication, patient population, dosing information, mechanism of action, clinical trial results, or safety findings. Those details are therefore not described here.
Approval details
The event was classified as FDA approval initial. The approval record’s external identifier was NDA217806-ORIG-1. The application summary lists the sponsor as Eli Lilly and Co. and assigns the application to FDA class Type 10, described in the data as a new indication submitted as a distinct NDA and not consolidated.
What this means
The FDA event confirms that Zepbound, the tirzepatide product named in the record, received an initial approval action on November 8, 2023. The available data establish the regulatory action and application classification but do not provide the approved use or comparative clinical evidence.
Because the supplied record contains no outcome measurements, statistical analyses, confidence intervals, p-values, adverse-event summaries, or treatment details, it cannot support conclusions about efficacy, safety, dosing, or how Zepbound compares with other treatments.
Source
Source: FDA, Drugs@FDA application overview for NDA 217806, dated November 8, 2023. The record is available at accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA217806.